Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)

FDA DeterminedCause 2

PRODUCTION CONTROLS: Process Control

Action

The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall.